FDA NDA 019084 – Nizoral (Ketoconazole) Cream 2% Labeling and Package Insert

This FDA record set includes the container and carton labeling for NIZORAL (Ketoconazole) Cream 2%, NDA 019084, along with the most recently approved package insert (PI). These materials reflect both current and historical versions on file with the agency and provide insight into the drug’s labeling history, dosage information, and approved indications.

Please note that labeling records obtained through FOIA may contain redactions for confidential commercial information. If you would like more details about this document before purchasing, please contact us at info@foiadocs.com.